Vertigo-Vomex SR delayed-release, 10 capsules

Vertigo-Vomex SR prolonged-release capsules. Active ingredient: Dimenhydrinate. Indications: For the symptomatic treatment of elderly patients with dizziness of various origins.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Vertigo-Vomex SR prolonged-release capsules 120 mg, hard capsule, for use in adults.
Active ingredient: Dimenhydrinate.

Read the entire package leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or even feel worse after 14 days, consult your doctor.

What this leaflet contains:

1. WHAT ARE VERTIGO-VOMEX SR RETARD CAPSULES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING VERTIGO-VOMEX SR RETARD CAPSULES?
3. HOW SHOULD VERTIGO-VOMEX SR RETARD CAPSULES BE TAKED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD VERTIGO-VOMEX SR RETARD CAPSULES BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT ARE VERTIGO-VOMEX SR RETARD-RELEASE CAPSULES AND WHAT ARE THEY USED FOR?

Vertigo-Vomex SR Retard Capsules are a dizziness medication from the H1 antihistamine group. Vertigo-Vomex SR Retard Capsules are taken for the symptomatic treatment of dizziness of various origins in elderly patients. If you do not feel better or even feel worse after 14 days, consult your doctor.

2. WHAT SHOULD YOU KNOW BEFORE TAKING VERTIGO-VOMEX SR RETARD-RELEASE CAPSULES?

Vertigo-Vomex SR Retard Capsules must not be taken:

• if you are allergic to dimenhydrinate, other antihistamines or any of the other ingredients of this medicine listed in section 6,
• in case of an acute asthma attack,
• in glaucoma (narrow-angle glaucoma),
• if you have an adrenal gland tumor (pheochromocytoma),
• if you suffer from a disorder in the production of blood pigment (porphyria),
• in cases of enlarged prostate gland (benign prostatic hyperplasia) with residual urine formation,
• if you suffer from seizures (epilepsy, eclampsia),
• for children under 14 years of age.

Warnings and precautions:
Please talk to your doctor or pharmacist before taking Vertigo Vomex SR prolonged-release capsules if you have:

• impaired liver function,
• Cardiac arrhythmias (e.g., rapid heartbeat),
• Potassium or magnesium deficiency,
• slowed heartbeat (bradycardia),
• certain heart conditions (congenital QT syndrome or other clinically significant heart damage, especially coronary artery disease, conduction disorders, arrhythmias),
• simultaneous use of drugs that also prolong the so-called QT interval in the ECG or lead to hypokalemia (see under “Taking Vertigo-Vomex SR Retard capsules together with other drugs”),
• chronic respiratory problems and asthma,
• Narrowing at the exit of the stomach (pyloric stenosis).

Children and adolescents:
Vertigo-Vomex SR prolonged-release capsules must not be used in children under 14 years of age.

Taking Vertigo-Vomex SR prolonged-release capsules with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Taking Vertigo-Vomex SR prolonged-release capsules at the same time as other centrally acting depressants (medicines that affect the mind, sleeping pills, sedatives, painkillers, and anesthetics) may result in a mutual increase in their effects. The anticholinergic effects of Vertigo-Vomex SR prolonged-release capsules (see under "What side effects are possible?") can be unpredictably intensified by the simultaneous administration of other substances with anticholinergic effects (e.g., atropine, biperiden, or certain antidepressants [tricyclic antidepressants]). When Vertigo-Vomex SR prolonged-release capsules are taken concurrently with so-called monoamine oxidase inhibitors (medicines also used to treat depression), life-threatening paralytic ileus, urinary retention, or an increase in intraocular pressure may develop. Furthermore, a drop in blood pressure and increased impairment of central nervous system and respiratory function may occur. Therefore, Vertigo-Vomex SR prolonged-release capsules must not be taken concurrently with monoamine oxidase inhibitors.

Concurrent use with medicines that:

• They can also prolong the so-called QT interval in the ECG, for example, drugs for heart rhythm disorders (antiarrhythmics class IA or III), certain antibiotics (e.g. erythromycin), cisapride, malaria drugs, drugs for allergies or stomach/intestinal ulcers (antihistamines), or drugs for the treatment of specific mental illnesses (neuroleptics), or
• which can lead to potassium deficiency (e.g. certain diuretics)

This should be avoided.

Taking Vertigo-Vomex SR prolonged-release capsules together with medications for high blood pressure can lead to increased drowsiness. The doctor should be informed about taking Vertigo-Vomex SR prolonged-release capsules before allergy tests are performed, as false-negative test results are possible. Furthermore, it should be noted that Vertigo-Vomex SR prolonged-release capsules may mask hearing damage that may occur during treatment with certain antibiotics (aminoglycosides). Please note that this information may also apply to medications taken recently.

Taking Vertigo-Vomex SR prolonged-release capsules with alcohol:
No alcohol should be consumed during treatment with Vertigo-Vomex SR prolonged-release capsules, as alcohol can unpredictably alter and intensify the effects of Vertigo-Vomex SR prolonged-release capsules. Driving ability and the ability to operate machinery will also be further impaired.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy:
Dimenhydrinate, the active ingredient in Vertigo-Vomex SR prolonged-release capsules, can induce premature labor. The safety of using Vertigo-Vomex SR prolonged-release capsules during pregnancy has not been established. A risk associated with dimenhydrinate cannot be ruled out based on clinical data. You should only take Vertigo-Vomex SR prolonged-release capsules after consulting your doctor and only if they consider it absolutely necessary.

Breastfeeding:
Dimenhydrinate, the active ingredient in Vertigo-Vomex SR prolonged-release capsules, passes into breast milk. The safety of using Vertigo-Vomex SR prolonged-release capsules while breastfeeding has not been established. Since undesirable effects, such as increased restlessness, cannot be ruled out in the breastfed infant, you should either not take Vertigo-Vomex SR prolonged-release capsules while breastfeeding or discontinue breastfeeding during the period of use of Vertigo-Vomex SR prolonged-release capsules.

Driving and operating machinery:
Drowsiness, memory problems, and reduced concentration can adversely affect your ability to drive or operate machinery. This applies particularly after insufficient sleep, at the start of treatment and when switching medications, as well as in combination with alcohol (see also Taking Vertigo-Vomex SR prolonged-release capsules with other medicines).

Vertigo-Vomex SR prolonged-release capsules contain sucrose.
Please only take Vertigo-Vomex SR prolonged-release capsules after consulting your doctor if you know you have an intolerance to certain sugars.

3. HOW TO TAKE VERTIGO-VOMEX SR PROLONGED-RELEASE CAPSULES?

Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: One prolonged-release hard capsule in the morning and, if necessary, another in the late afternoon (corresponding to 120 mg or 240 mg dimenhydrinate per day). Up to three prolonged-release hard capsules (corresponding to 360 mg dimenhydrinate per day) can be taken within 24 hours, preferably at 8-hour intervals.

Method of administration:
Vertigo-Vomex SR prolonged-release capsules should be swallowed whole with plenty of liquid.

Duration of use:
Unless otherwise prescribed by a doctor, Vertigo-Vomex SR prolonged-release capsules are intended for short-term use only. If symptoms persist, a doctor should be consulted. After a maximum of two weeks of treatment, your doctor should assess whether continued treatment with Vertigo-Vomex SR prolonged-release capsules is necessary.

If you have taken more Vertigo-Vomex SR prolonged-release capsules than you should:
Poisoning with dimenhydrinate, the active ingredient in Vertigo-Vomex SR prolonged-release capsules, can be life-threatening. Children are particularly at risk. In case of an overdose or poisoning with Vertigo-Vomex SR prolonged-release capsules, a doctor (e.g., a poison control center) should be consulted immediately. An overdose of Vertigo-Vomex SR prolonged-release capsules is primarily characterized by impaired consciousness, ranging from severe drowsiness to unconsciousness. Other symptoms include: dilated pupils, visual disturbances, rapid heartbeat, fever, hot, flushed skin and dry mucous membranes, constipation, agitation, increased reflexes, and hallucinations. Seizures and respiratory problems are also possible, which, after high doses, can lead to respiratory paralysis and cardiac arrest. The severity of the poisoning and the necessary treatment will be assessed by a doctor.

If you forget to take Vertigo-Vomex SR prolonged-release capsules:
Do not take a double dose to make up for a missed dose. Instead, continue taking Vertigo-Vomex SR prolonged-release capsules as directed in this leaflet or as prescribed by your doctor.

If you stop taking Vertigo-Vomex SR prolonged-release capsules:
Please do not interrupt or stop taking Vertigo-Vomex SR prolonged-release capsules without first consulting your doctor.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects:
Depending on individual sensitivity and the dose taken, the following side effects occur very frequently – especially at the beginning of treatment: drowsiness, dizziness, lightheadedness, and muscle weakness. These side effects can also cause impairment the following day. Commonly occurring anticholinergic side effects include dry mouth, increased heart rate (tachycardia), nasal congestion, visual disturbances, increased intraocular pressure, and difficulty urinating. Gastrointestinal problems (e.g., nausea, stomach pain, vomiting, constipation, or diarrhea) and mood swings have also been observed. Furthermore, especially in children, so-called paradoxical reactions such as restlessness, agitation, insomnia, anxiety, or tremors may occur. Allergic skin reactions, photosensitivity (avoid direct sunlight!), and liver dysfunction (cholestatic jaundice) have also been reported. Blood cell damage can occur in rare cases.

Other possible side effects:
With prolonged treatment using dimenhydrinate, the development of drug dependence cannot be ruled out. For this reason, Vertigo-Vomex SR prolonged-release capsules should, if possible, only be used for short periods. After prolonged daily use, temporary sleep disturbances may occur if treatment is stopped abruptly. Therefore, in these cases, treatment should be discontinued by gradually reducing the dose.

Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VERTIGO-VOMEX SR PROLONGED-RELEASE CAPSULES:

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister pack after EXP. The expiry date refers to the last day of that month. Storage conditions: Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vertigo-Vomex SR prolonged-release capsules contain:
The active ingredient is dimenhydrinate. One prolonged-release hard capsule contains 120 mg of dimenhydrinate. The other ingredients are: talc, sucrose, maize starch, shellac, povidone K 30, titanium dioxide, gelatin, quinoline yellow, indigo carmine, and erythrosine.

Appearance of Vertigo-Vomex SR prolonged-release capsules and contents of the pack:
Hard gelatin capsules (cap reddish-brown/opaque, cap green/transparent), filled with granules. Vertigo-Vomex SR prolonged-release capsules are available in packs of 10, 20, 50, or 100 prolonged-release hard capsules.

(Apo) Usually ship out within 3-5 business days